A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP) (FIT)

January 24, 2019 updated by: Rigel Pharmaceuticals

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rankweil, Austria, 6830
        • LKH Feldkirch at LKH Rankweil
    • AU
      • Vienna, AU, Austria, 1140
        • Hanusch-Krankenhaus Wiener Gebietskrankenkasse
      • Wien, AU, Austria, 1090
        • Medizinische Universitaet Wien / AKH Wien
      • Pleven, Bulgaria, 5800
        • UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology
      • Sofia, Bulgaria, 1431
        • UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology
    • BG
      • Sofia, BG, Bulgaria, 1756
        • Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology;
      • Vratsa, BG, Bulgaria, 3000
        • MHAT Hristo Botev, AD, Vratsa, First Internal Department
      • Ostrava-Poruba, Czechia, 708 52
        • Fakultni nemocnice Ostrava
      • Praha 10, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Praha 2, Czechia, 128 08
        • Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie
    • CZ
      • Brno, CZ, Czechia, 625 00
        • Fakultni nemocnice Brno
      • Kyjov, CZ, Czechia, 69733
        • Hospital Kyjov
      • Berlin, Germany, 12203
        • Charit Berlin - Campus Benjamin Franklin
      • Duesseldorf, Germany, 40479
        • Marien Hospital Duesseldorf
      • Essen, Germany, 45147
        • Universittsklinikum Essen
    • DE
      • Giessen, DE, Germany, 35392
        • Universitaetsklinikum Giessen und Marburg (UKGM)
      • Hannover, DE, Germany, 30159
        • Werlhof Institut GmbH
      • Bergen, Norway, 5021
        • Haukeland University Hospital
      • Fredrikstad, Norway, 1606
        • Sykehuset Østfold Fredrikstad
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland, 31-501
        • Szpital Uniwersytecki
      • Lodz, Poland, 93-510
        • Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
      • Lublin, Poland, 20-081
        • Specjalistyczny Gabinet Lekarski
      • Opole, Poland, 45-064
        • Szpital Wojewodzki w Opolu
      • Slupsk, Poland, 76-200
        • Wojewodzki Szpital Specjalistyczny im. J. Korczaka
      • Warszawa, Poland, 02-776
        • Instytut Hematologii i Transfuzjologii
      • Wroclaw, Poland, 50-367
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw
      • Bucuresti, Romania, 020125
        • Spitalul Clinic Colentina, Hematologie
      • Bucuresti, Romania, 030171
        • Spitalul Clinic Coltea, Hematologie
    • Mures
      • Targu Mures, Mures, Romania, 540136
        • Spitalul Clinic Judetean de Urgenta Tirgu-Mures, Sectia Medicina Interna 1, Compartiment Hematologie
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Madrid, Spain, 28046
        • Hospital Universitariola Paz
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
    • New York
      • Nyack, New York, United States, 10960
        • Hematology Oncology Associates of Rockland Division of Highland Medical PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of persistent/chronic ITP for at least 3 months
  • Average platelet count< 30,000/µL (and none > 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts

Exclusion Criteria:

  • Clinical diagnosis of autoimmune hemolytic anemia
  • Uncontrolled or poorly controlled hypertension
  • History of coagulopathy including prothrombotic conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fostamatinib Disodium
Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
Other Names:
  • R935788
  • Fostamatinib
  • R788
OTHER: Placebo
Placebo tablet PO bid (morning and evening) over the course of 24 weeks
Placebo tablet PO bid (morning and evening)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Stable Platelet Response of at Least 50,000/µL
Time Frame: Baseline to Week 24
Stable platelet response by Week 24 defined as a platelet count of at least 50,000/µL on at least 4 of the 6 visits between Weeks 14-24
Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Platelet Count ≥ 50,000/µL at Week 12
Time Frame: Baseline to Week 12
Platelet Count ≥ 50,000/µL at Week 12
Baseline to Week 12
Number of Participants With Platelet Count ≥ 50,000/µL at Week 24
Time Frame: Baseline to Week 24
Platelet Count ≥ 50,000/µL at Week 24
Baseline to Week 24
Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 12
Time Frame: Baseline to Week 12
Among subjects with a baseline platelet count < 15,000/μL, achievement of a count ≥ 30,000/μL and at least 20,000/μL above baseline at Week 12.
Baseline to Week 12
Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 24
Time Frame: Baseline to Week 24
Among subjects with a baseline platelet count < 15,000/μL, achievement of a count ≥ 30,000/μL and at least 20,000/μL above baseline at Week 24
Baseline to Week 24
Frequency and Severity of Bleeding According to the ITP Bleeding Score (IBLS)
Time Frame: Baseline to Week 24

The ITP Bleeding Scale (IBLS) is an immune thrombocytopenic purpura (ITP)-specific bleeding score used to analyze the correlation of clinical and laboratory platelet variables with bleeding. The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage. After each grade is scored, the mean value for all 11 grades is calculated (lowest score being 0 and highest score being 2) for each subject visit. LOCF method was used to impute any missing data.

The mean of the IBLS scores across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint.

Baseline to Week 24
Frequency and Severity of Bleeding According to the World Health Organization (WHO) Bleeding Scale
Time Frame: Baseline to Week 24

The World Health Organization (WHO) bleeding scale is a standardized grading scale created to measure the severity of bleeding. The scale is a clinical investigator-assessed five-point scale with a score range starting at the lowest 0=No bleeding, 1 = Petechiae, 2=Mild blood loss, 3=Gross blood loss, to the worse 4=Debilitating blood loss. The WHO bleeding scale is scored by history over the previous-week or by exam. After each grade is scored, the mean value is calculated (lowest score being 0 [no bleeding] to the highest score being 4 [debilitating blood loss]) for each visit. LOCF method was used to impute any missing data.

The mean of the WHO bleeding scale across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint.

Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (ESTIMATE)

March 3, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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